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Device
prosthesis, knee, femorotibial, non-constrained, cemented, metal/polymer
Regulation Description
Knee joint femorotibial metal/polymer non-constrained cemented prosthesis.
Regulation Medical Specialty
Orthopedic
Review Panel
Orthopedic
Product Code
HSX
Premarket Review
Joint Arthroplasty Devices
(DHT6A)
Joint Arthroplasty Devices (DHT6A)
Submission Type
510(k)
Regulation Number
888.3520
Device Class
2
Total Product Life Cycle (TPLC)
TPLC Product Code Report
GMP Exempt?
No
Summary Malfunction
Reporting
Eligible
Implanted Device?
Yes
Life-Sustain/Support Device?
No
Recognized Consensus Standards
8-368 ASTM F2625-10 (Reapproved 2016)
Standard Test Method for Measurement of Enthalpy of Fusion, Percent Crystallinity, and Melting Point of Ultra-High-Molecular Weight Polyethylene by Means of Differential Scanning Calorimetry
8-378 ASTM D792-13
Standard Test Methods for Density and Specific Gravity (Relative Density) of Plastics by Displacement
8-379 ISO 11542-2 First edition 1998-11-15
Plastics - Ultra-high-molecular-weight polyethyelene (PE-UHMW) moulding and extrusion materials - Part 2: Preparation of test specimens and determination of properties [Including: Technical Corrigendum 1 (2007)]
8-403 ASTM D638-14
Standard Test Method for Tensile Properties of Plastics
8-404 ASTM E647-15
Standard Test Method for Measurement of Fatigue Crack Growth Rates
8-495 ISO 5834-3 Second edition 2019-02
Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 3: Accelerated ageing methods
8-496 ISO 5834-4 Second edition 2019-02
Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 4: Oxidation index measurement method
8-497 ISO 5834-5 Second edition 2019-02
Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 5: Morphology assessment method
8-501 ISO 5834-1 Fourth edition 2019-02
Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 1: Powder form
8-514 ISO 5834-2 Fifth edition 2019-02
Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 2: Moulded forms
8-572 ASTM F2565-21
Standard Guide for Extensively Irradiation-Crosslinked Ultra-High Molecular Weight Polyethylene Fabricated Forms for Surgical Implant Applications
8-573 ASTM F2695-12(2020)
Standard Specification for Ultra-High Molecular Weight Polyethylene Powder Blended With Alpha-Tocopherol (Vitamin E) and Fabricated Forms for Surgical Implant Applications
11-197 ASTM F983-86 (Reapproved 2018)
Standard Practice for Permanent Marking of Orthopaedic Implant Components
11-199 ASTM F565-04 (Reapproved 2018)
Standard Practice for Care and Handling of Orthopedic Implants and Instruments
11-232 ISO 7207-1 Third edition 2007-02-01
Implants for surgery - Components for partial and total knee joint prostheses - Part 1: Classification, definitions and designation of dimensions
11-308 ASTM F3161-16
Standard Test Method for Finite Element Analysis (FEA) of Metallic Orthopaedic Total Knee Femoral Components under Closing Conditions
11-311 ISO 14243-2 Third edition 2016-09-01
Implants for surgery - Wear of total knee-joint prostheses - Part 2: Methods of measurement
11-335 ASTM F3141-17a
Standard Guide for Total Knee Replacement Loading Profiles
11-342 ASTM F732-17
Standard Test Method for Wear Testing of Polymeric Materials Used in Total Joint Prostheses
11-364 ISO 14243-1 Second edition 2009-11-15
Implants for surgery - Wear of total knee-joint prostheses - Part 1: Loading and displacement parameters for wear-testing machines with load control and corresponding environmental conditions for test [Including AMENDMENT1 (2020)]
11-365 ASTM F1800-19 e1
Standard Practice for Cyclic Fatigue Testing of Metal Tibial Tray Components of Total Knee Joint Replacements
11-366 ASTM F2381-19
Standard Test Method for Evaluating Trans-Vinylene Yield in Irradiated Ultra-High Molecular Weight Polyethylene Fabricated Forms Intended for Surgical Implants by Infrared Spectroscopy
11-367 ISO 14243-3 Second edition 2014-11-01
Implants for surgery - Wear of total knee-joint prostheses - Part 3: Loading and displacement parameters for wear-testing machines with displacement control and corresponding environmental conditions for test [Including AMENDMENT1 (2020)]
11-368 ASTM F3334-19
Standard Practice for Finite Element Analysis (FEA) of Metallic Orthopaedic Total Knee Tibial Components
11-370 ISO 14879-1 Second edition 2020-07
Implants for surgery - Total knee-joint prostheses - Part 1: Determination of endurance properties of knee tibial trays
11-373 ASTM F1223-20
Standard Test Method for Determination of Total Knee Replacement Constraint
11-374 ISO 7207-2 Second edition 2011-07-01
Implants for surgery - Components for partial and total knee joint prostheses - Part 2: Articulating surfaces made of metal, ceramic and plastics materials [Including AMENDMENT 1 (2016) and AMENDMENT 2 (2020)]
11-377 ASTM F2083-21
Standard Specification for Knee Replacement Prosthesis
11-395 ASTM F1814-22
Standard Guide for Evaluating Modular Hip and Knee Joint Components
11-397 ASTM F3210-22e1
Standard Test Method for Fatigue Testing of Total Knee Femoral Components Under Closing Conditions
11-400 ISO 21536 Third edition 2023-07
Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants
11-406 ASTM F3141-23
Standard Guide for Total Knee Replacement Loading Profiles
11-408 ASTM F2777-23
Standard Test Method for Evaluating Knee Bearing (Tibial Insert) Endurance and Deformation Under High Flexion
Third Party Review
Not Third Party Eligible
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